Drug Evaluation Committee 2012-52 Necessity of Signatures on Case Report Forms by Clinical Trial Collaborators

Related classification: Other

First published: May 2013
Revised publication date: December 2021

Question

We are currently using a paper CRF, but the CRF does not have a signature line for a study collaborator. When we inquired with the sponsor, we received the opinion that the investigator's signature on each CRF is not necessary because the monitor checks the entered characters using a list of signature impressions.

As we have no experience with CRFs that did not have a signature column for the investigator's signature, we would like to ask for your opinion on whether we can use the signature impression as collateral for the report.

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Article 47, paragraph 1 of the GCP stipulates that "The investigator* must accurately prepare the case report form in accordance with the study protocol and enter the name of the investigator in the form. GCP does not require the inclusion of the name of the collaborator in the case report form. Paragraph 3 of the same article states, "The investigator shall inspect the case report form prepared by the subinvestigator, confirm its contents, and enter the name of the subinvestigator in the form. The investigator is to inspect the contents of the case report form and enter the investigator's name on it.

Although investigators may assist in the preparation, modification or revision of the case report form, the investigator who is responsible for the contents of the case report form is required to ensure that the investigator's name is written on the report form.

Reason for revision of opinion

In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3), the opinion text has been partially changed.

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